FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
- Recall number
- Z-2344-2018
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
- Status
- Terminated
- Initiated
- 2018-05-09
- Posted
- not on file
- Terminated
- 2020-08-18
- Reason
- There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
- Root cause
- Under Investigation by firm
- Action
- Urgent Product Correction Notification letters were distributed on 5/9/18. The letters instruct customers to do the following: " Immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. " Complete the Confirmation of Receipt form no later than May 23, 2018. Ortho will replace your remaining inventory of the affected lots or credit your account. " Post this notification by each VITROS System in your facility or with the user documentation. " Forward this notification if the product was distributed outside of your facility. If the customer is a distributor, they were also instructed to: " Send the letter to all customers who were shipped an affected lot of VITROS PHYT Slides.
- Quantity
- 5712
- Distribution
- Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden
- Lot, serial or model codes
- Lot Numbers: 2616-0165-4866, 2616-0165-4904, 2616-0165-4870, 2616-0165-4869, 2616-0165-5266, 2616-0165-5307, 2616-0165-5233, 2616-0165-5232, 2616-0165-5611, 2616-0165-5610, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6275, 2616-0165-6220, 2616-0165-6221, 2616-0165-6219, 2616-0165-6276, 2616-0165-6791, 2616-0165-6832, 2616-0165-6792, 2616-0165-6787, 2616-0165-7225, 2616-0165-7226, 2616-0165-7223, 2616-0165-7214, 2616-0165-7222
- 510(k) numbers
- ["K081543","K941142"]
- PMA numbers
- not on file
- Product code
- DIP
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28